NCT06351969

Brief Summary

Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placental attachment in the prediction of postpartum hemorrhage in cases of placenta previa accreta and to evaluate both of them as as parameters for identifying high-risk patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

March 28, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

March 28, 2024

Last Update Submit

June 3, 2025

Conditions

Keywords

Post Partum Hemorrhageplacental thicknesscesarean sectionvaginal delivery

Outcome Measures

Primary Outcomes (1)

  • Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta

    Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta

    follow up blood loss in ml intraoperative and 24 hour post operative

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will be carried out on 100 pregnant women, who will undergo delivery either by vaginal delivery or cesarean section either as elective palnned at operative list or admitted to Obstetrics ER after complete clinical evaluation

You may qualify if:

  • Term pregnancy (37 wk gastation and more )
  • Single viable fetus

You may not qualify if:

  • Severe hematological disorders that could cause abnormal coagulation
  • Previous history of PPH
  • twins
  • Preterm labour
  • IUFD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Benha University

Banhā, benha, 13511, Egypt

Location

B Univeristy

Banī Suwayf, Egypt

Location

Related Publications (6)

  • WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.

    PMID: 28456509BACKGROUND
  • Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, Gulmezoglu AM; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Aug 23;379(8):743-752. doi: 10.1056/NEJMoa1805489. Epub 2018 Jun 27.

    PMID: 29949473BACKGROUND
  • Ononge S, Mirembe F, Wandabwa J, Campbell OM. Incidence and risk factors for postpartum hemorrhage in Uganda. Reprod Health. 2016 Apr 14;13:38. doi: 10.1186/s12978-016-0154-8.

    PMID: 27080710BACKGROUND
  • Weeks A. The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next? BJOG. 2015 Jan;122(2):202-10. doi: 10.1111/1471-0528.13098. Epub 2014 Oct 7.

    PMID: 25289730BACKGROUND
  • Liao JB, Buhimschi CS, Norwitz ER. Normal labor: mechanism and duration. Obstet Gynecol Clin North Am. 2005 Jun;32(2):145-64, vii. doi: 10.1016/j.ogc.2005.01.001.

    PMID: 15899352BACKGROUND
  • B-Lynch, C., Keith, L., Lalonde, A. & Karoshi, M. (2006). A textbook of postpartum haemorrhage: a comprehensive guide to evaluation,managementand surgical intervention, New Delhi, India, Japee Brothers

    BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed A A, resident

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 8, 2024

Study Start

June 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations